In preparation for the January 21, 2019, revised Common Rule compliance date, Advarra has published several new and updated client resources. These documents are available in the Reference Materials section of the Advarra Center for IRB Intelligence (CIRBI) Platform.
- IRB Handbook – This has been revised to address the Common Rule changes and includes details on when compliance with the revised Common Rule is required and how to comply.
- A separate summary of these revisions is also available.
- ICF Templates – New ICF and short form consent templates are available for use in new federally funded studies approved on or after January 21, 2019. The templates include the new Key Information section and 4 new consent elements.
- Advarra also offers ICF and short form consent templates for FDA-regulated research, federally funded research approved before January 21, 2019, and non-funded research.
- Guidance on Compliance with the Revised Common Rule ICF Changes – This guidance document describes the revised Common Rule’s new ICF elements and other ICF changes and provides tips for implementing the requirements.
- Guidance on Exemption Categories – This guidance document describes the new and revised exemption categories and provides information on whether the exemptions can be applied for research involving vulnerable populations.
For more information on the revised Common Rule, refer to OHRP’s revised Common Rule resources. For assistance in implementing these requirements for a new study submission, contact Business Development.